COD-ACAMOL 15325

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

CODEINE PHOSPHATE; PARACETAMOL

Beschikbaar vanaf:

TEVA ISRAEL LTD

ATC-code:

N02BE51

farmaceutische vorm:

TABLETS

Samenstelling:

PARACETAMOL 325 MG; CODEINE PHOSPHATE 15.0 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutisch gebied:

PARACETAMOL, COMBINATIONS EXCL. PSYCHOLEPTICS

therapeutische indicaties:

Relief of mild to moderate pain. Relief of fever and cough associated with fever.

Autorisatie datum:

2014-06-30

Bijsluiter

COD ACA TAB PL SH 020222
COD ACA TAB PL SH 020222
PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
COD ACAMOL
® 15/325
TABLETS
COMPOSITION
Each tablet contains:
Paracetamol 325 mg
Codeine Phosphate 15 mg
For information on the inactive and allergenic
ingredients in the preparation, see section
2 “Important information about some of the
ingredients of the medicine” and section 6 –
“Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed to treat
you. Do not pass it on to others. It may
harm them even if it seems to you that their
medical condition is similar.
THIS MEDICINE IS NOT INTENDED FOR
CHILDREN BELOW 12 YEARS OF AGE.
•
PROLONGED USE MAY CAUSE DEPENDENCE!
• THIS MEDICINE CONTAINS CODEINE
WHICH IS AN OPIOID THAT CAN CAUSE
ADDICTION. YOU CAN DEVELOP WITHDRAWAL
SYMPTOMS IF YOU STOP USE ABRUPTLY.
Consult the doctor if needed.
• Medicines containing codeine should
only be used for treatment of acute pain
(of short duration) of moderate intensity
in adolescents above 12 years of age
and only if the pain cannot be treated
by pain relievers such as paracetamol or
ibuprofen; this is in view of the fact that
use of codeine may increase the risk of
respiratory depression.
MEDICINES FROM THE OPIOID GROUP
MAY CAUSE ADDICTION, ESPECIALLY WITH
PROLONGED USE, AND HAVE THE POTENTIAL
FOR MISUSE AND OVERDOSE. A REACTION TO
AN OVERDOSE CAN BE MANIFESTED BY SLOW
BREATHING AND CAN EVEN CAUSE DEATH.
MAKE SURE YOU KNOW THE NAME OF THE
MEDICINE, THE DOSAGE YOU ARE TAKING,
THE FREQUENCY OF ADMINISTRATION, THE
DURATION OF TREATMENT, THE SIDE EFFECTS
AND THE POTENTIAL RISKS.
ADDITIONAL INFORMATION ABOUT THE RISK
OF DEPENDENCE AND ADDICTION CAN BE
FOUND AT THE LINK:
https://www.health.gov.il/UnitsOffice/HD/
MTI/Drugs/

Productkenmerken

Cod Acamol 15/325 tablets MW Aug 2023
SUMMARY OF PRODUCT CHARACTERISTICS
COD ACAMOL

15/325
TABLETS
BOXED WARNINGS
WARNING: Death related to ultra-rapid metabolism of codeine to
morphine respiratory depression
and
death
have
occurred
in
children
who
received
codeine
following
tonsillectomy
and/or
adenoidectomy and had evidence of being ultra-rapid metabolizers of
codeine due to a CYP2D6
polymorphism (see section 4.3 contra indications and section
4.4.Special warnings and precautions for
use).
1.
NAME OF THE MEDICINAL PRODUCT
COD ACAMOL

15/325
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Paracetamol 325 mg
Codeine phosphate 15 mg_ _
Excipients with known effect:
Each tablet contains 78.66 mg lactose monohydrate.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Light blue round flat tablets with white flakes and beveled edges,
Scored in half on one side, debossed
"IKA’ on the other side.
There is no information regarding chewing or crushing the tablets.
The tablets may be divided.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic Indications
Relief of mild to moderate pain.
Relief of fever and cough associated with fever.
For usage in children see section 4.4 "Special warnings and
precautions for use".
2
Cod Acamol 15/325 tablets MW Aug 2023
4.2.
Posology and method of administration
Method of administration: Oral
_Adults and Adolescents above the age of 12 Years _
1-2 tablets every 4-6 hours, as needed.
Dosage should not exceed 8 tablets in 24 hours.
This product should only be taken for a maximum of 3 days at a time.
If needed to be taken for longer
than 3 days the physician should be consulted
If this medicine is taken for headaches for more than three days it
can make them worse.
4.3.
Contraindications
•
Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1.
•
Children under 12 years of age.
•
Cod Acamol is contraindicated in patients with moderate to severe
degrees of renal or hepatic
impairment.
•
It is contraindica